How to Best Prepare for Final DSCSA Deadlines

As highlighted numerous times since its announcement, the FDA has provided an exemption for certain eligible trading partners from Enhanced Drug Distribution Security (EDDS) Requirements of the Drug Supply Chain Security Act (DSCSA). These exemptions vary in length depending on the trade partner; for manufacturers and repackagers, the deadline for compliance is May 27th, 2025... less than four short months away. For other types of eligible trading partners, the deadlines come shortly after.?

Tracy Nasarenko, Vice President of Consumer Success (Healthcare) at GS1 US, recently published an article emphasizing the importance of data quality for adherence to DSCSA guidelines. If a trading partner has missing/incorrect information in their master data (i.e. GLNs or GTINs), exceptions and possible quarantines could be the result; situations like this may prevent patients from receiving necessary medications.?

Recall that potential supply chain delays were the main reason the FDA implemented the stabilization period (as well as the recent October 10th exemption) in the first place. The FDA was concerned that with not enough trading partners prepared to send and receive interoperable data, extensive product and data delays could inhibit millions of patients from receiving medications in a timely manner.?

However, following numerous delays and exemptions, its more than likely the May 27th deadline for manufacturers and repackagers will remain in stone. Additionally, given how much time has been allotted for trade partners to prepare their systems and meet DSCSA requirements, not as much leeway will be given by the FDA for those who aren’t ready.??

While adhering to the requirements of the DSCSA may seem a bit overwhelming, here's a few tips that will help simplify the process:?

1. Understand the law and exemptions: Review materials pertaining to the DSCSA, including FDA guidances and the DSCSA itself, to ensure you and your trading partners understand what the law actually mandates. Understanding the details of the recent exemption (who it applies to, and until when) is also essential.?
2. Ensure interoperability of systems: make sure your systems are prepared to seamlessly exchange information with your trading partners. Interruptions in the digital exchange of information will interrupt the physical flow of product.?
3. Get tested: test data exchanges with your trading partners to address potential connectivity complications. Gateway Checker offers the only independent, GS1 Certified Conformance Testing Service, allowing trade partners to proactively identify and remediate conformance and interoperability issues.?
4. Communication: the HDA previously released a “DSCSA Lessons Learned’ Webinar, and a highlight of the conversation was the importance of communication. Given the complexity of the supply chain, different trading partners have different ways of ensuring compliance. Communicating these processes with your trading partners is key.?
5. Don’t Wait: compliance has moved from a future consideration to a present-day necessity. Wherever your progress is in reaching full DSCSA conformance, learn how Gateway Checker can help by visiting our website.?